The road to resource efficiency

The introduction of the Hazardous Waste Regulations (which apply to the UK — equivalent legislation would be implemented in other EC states) in July 2005 had a significant impact on the chemical and pharmaceutical industries.^1,2 Several categories of waste were newly classified as hazardous waste on publication of the revised EC's European Waste Catalogue, yet appropriate landfill and incineration sites are still limited, meaning a transport premium is often paid by companies using these disposal methods. And, with landfill tax on the rise, the cost of waste disposal can be a real burden to companies.

Additionally, the Registration, Evaluation and Authorisation of Chemicals (REACH) regulations that came into force from 1 June 2007 set a framework for assessing the environmental and health risks of chemicals.³ Under the regulations, the onus will be on each and every business to demonstrate that their products are safe, which could involve substituting hazardous chemicals with safer alternatives. There is also the risk that manufacturers may stop supplying certain chemicals or substances that would require companies in that supply chain to source alternatives.

Another driver within the pharmaceutical sector is the pressure put on the companies by stakeholders to be environmentally proactive. These stakeholders include, amongst others, shareholders, employees, local communities and nongovernmental organizations. Pharmaceutical companies need to demonstrate that they are committed to environmental improvements. The UK's Chemical Industries Association's Responsible Care Initiative (RCI) is a good example of a global voluntary programme where companies are working together to improve health, safety and environmental performances, and communicate information on their products and processes to stakeholders.

Many larger companies will already be following environmental improvement programmes as part of the Integrated Pollution Prevention and Control (IPPC) regulations.⁴ This requires companies to demonstrate that they are considering the environmental impact of a new drug at the design phase, not just at the final manufacturing stage.

Measuring and managing environmental impact is becoming an increasingly strategic business issue, which is why Envirowise is encouraging companies in the sector to commit fully to resource efficiency. Essentially, resource efficiency means using raw materials, water and energy more effectively and cutting down on waste whenever possible.

Envirowise

Green chemistry

The application of green chemistry could be an excellent route for pharmaceutical companies to improve their resource efficiency.

Green chemistry describes the process of designing chemical products and processes with the reduction or elimination of hazardous substance use in mind. Applying Green chemistry principles can improve resource efficiency and lead to significant commercial benefits. Examples include:

• The savings associated with reduced waste disposal costs.

• Lower energy by replacing toxic catalysts with enzyme catalysts.

• Eliminating hazardous filter aids.

• Eliminating local exhaust ventilation by using water-based printing inks.

Furthermore, as described earlier, REACH is likely to prompt manufacturers to consider substituting hazardous substances with replacement materials — and the principles of green chemistry could form an excellent foundation for this process.

To support businesses, the programme has published a new practical guide — Resource Efficiency through Green Chemistry — that examines the significant benefits of implementing green chemistry and outlines a framework in which this can be achieved.⁵ The guide will be useful to chemical manufacturers across a range of product areas, including speciality and bulk chemicals, pharmaceuticals, paints, adhesives and plastics.

It demonstrates how these principles can work in practice and recommendations include:

• Making a detailed assessment of the chemicals you currently use and manufacture.

• Developing an integration plan based on the twelve principles of green chemistry.

• Appointing a multidisciplinary team and 'champion' to drive forward the ongoing activity.

• Brainstorming innovative ideas that could lead to the production of products with lower environmental impact.

• Considering formalizing the integration of green chemistry into the business by using a documented programme within a wider environmental management system (EMS).

• Regularly reviewing progress to ensure that processes continue to lead to environmental improvements.

Green chemistry has evolved considerably during the last decade and there is now increasing interest in adopting the practice on a more commercial scale. Implementation of the key principles could help businesses achieve measurable business benefits and help them adapt to a changing marketplace.

Packaging

One of the largest sources of waste within the pharmaceutical sector is the packaging from raw materials delivered to the site. The types of packaging waste produced are:

• pallets

• cartons

• cardboard outers

• shrink wrap

• vials

• bottles (glass, plastic, Teflon-coated, etc).

Because of the strict legislation surrounding the transportation and shipping of materials (especially exporting), there are barriers to the reuse of some packaging within the pharmaceutical sector. Pallets are a particular problem, with many companies having to use brand new pallets instead of pallets already in circulation because there are concerns about wooden fibres possibly having an effect on the quality of the product.

However, in other areas there is potential for innovative approaches to reuse and recycle. Some smaller pharmaceutical companies are cutting costs and materials by using shredded office paper as packaging fillers. Other larger companies have been exploring options for changing the delivery and storage containers of packaging materials such as low density polyethylene (LDPE) beads that are used to produce plastic vials. Bulk ordering could also help bring packaging waste down.

Key points

Hazardous waste

It is estimated that the organic sector, which includes pharmaceuticals, produces 500000 tonnes of hazardous waste per year from companies regulated by the Environment Agency in England and Wales.

With the recent reduction in the number of UK landfill sites that can receive hazardous waste, the industry has been forced to consider alternatives. Current practices include the incineration of solid and liquid wastes, use as a chemfuel (and the recovery of energy), and the biological and chemical treatment of hazardous wastes.

However, companies should always be prioritizing prevention, elimination and reduction over recycling and recovery as the most effective ways of making resource efficiency savings. While all manufacturing sites are different, there are a number of key process areas where companies could see results.

Vessel design is one such area. Larger volume chemical manufacturing processes frequently use vessels for mixing, reaction and product separation. When replacing existing vessels, consider any 'blind spots' during mixing or poor drainage, and ensure new vessel designs facilitate cleaning-in-place and automated charging/emptying.

For both batch and continuous manufacturing processes, it is important to optimize the yield achieved. Mass balances help to identify where the greatest losses are occurring and highlight opportunities to reduce or recycle solvents. Also, spillages can often be reduced by arranging to add whole containers of material to a batch, or using automated filling. Setting monthly or annual benchmarks for product yield can provide a valuable guide to overall efficiency.

Organic solvents are used extensively throughout the chemical and pharmaceutical industries, as both reaction solvents and as cleaning agents. By monitoring for losses, faulty equipment or poor operator practice, companies can help combat unnecessary solvent consumption at the outset. Solvent waste can also be tackled via a solvent management plan that identifies a systematic approach to eliminating or reducing solvent use and optimizing reuse or recovery.

Notably, a large proportion of hazardous waste leaving a manufacturing site may be in solution, meaning the management of water and its role as solvent, reagent, dilutant or washing medium is crucial. Careful metering and measurement, as well as improved cleaning practices, production scheduling and efficient vessel design can all help reduce waste in solution.

Water

In most pharmaceutical manufacturing sites water is used in the manufacturing process, as well as for domestic use (e.g., office washrooms, kitchen areas within industry). Great savings can be made quite easily by reducing and monitoring water use; for example, installing simple measures such as spray taps, urinal controls and electric vacuum pumps, and reusing a process effluent as scrubber liquor can lead to savings of £20000–£30000 (€28000–€42000) per annum.

Water used for cooling is another key area. For example, establishing a recirculation programme to minimize water losses and to allow the reuse of water through the coolant system, rather than single pass through. This can reduce water consumption by 25%. CIP systems also offer the potential for water savings.

Energy

Alongside environmental objectives, the large increases in electricity and gas costs have acted as a driver towards implementation of energy efficiency improvements. There is a range of ways that pharmaceutical companies can minimize their energy use. These include:

• Switch off campaigns (computers, lights and equipment).

• Utility monitoring (meter readings/half hourly data).

• Replacement of lights with low energy lamps.

• Energy (building management systems).

• Compressed air system improvements.

In most cases, these initiatives can achieve 5–10% in energy savings, with the potential for more following investment in up-to-date equipment such as boilers, air conditioning and insulation.

A sustainable future

In the face of ever-growing international competition, pharmaceutical companies need to be creative in finding ways to improve their performance. And, with shareholders, employees, customers and communities alike increasingly calling on industry to be proactive about lowering its environmental impact, resource efficiency has never been so important.

References

1. www.opsi.gov.uk/SI/si2005/20050894.htm#3

2. www.opsi.gov.uk/SI/si2005/20050895.htm

3. Registration, Evaluation and Authorisation of Chemicals (REACH) regulations www.hse.gov.uk/chemicals/reach.htm

4. www.opsi.gov.uk/si/si2000/20001973.htm

5. Envirowise, GG679 Resource Efficiency Through Green Chemistry www.envirowise.gov.uk/GG679

Further information:

1. www.envirowise.gov.uk/chemicals

2. http://ec.europa.eu/environment/waste/index.htm

3. http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm

4. www.cefic.be

5. www.cia.org.uk

Geoff Leaver works for the UK government funded Envirowise programme to promote greater resource efficiency within the UK pharmaceutical and chemical industry. He qualified in chemical and biochemical engineering, and has worked on a range of projects and programmes in sectors including the food industry, industrial and environmental biotechnology, and biopharmaceutical production.